Kornimate/medical-research-clean huggingface dataset:
to evaluate the efficacy and safety of tegileridine and oliceridine injections in the treatment of postoperative pain

Conditions: Analgesia

Summary: this was a single-center, randomized, open-label, controlled exploratory study conducted in chinese patients. the study planned to enroll chinese patients to evaluate the efficacy and safety of tegileridine and oliceridine injection in the treatment of postoperative pain.


Eligibility criteria:
inclusion criteria: 1. accept elective laparoscopic combined thoracic surgery under general anesthesia, surgery time ≥ 1 h; 2. 18 years old ≤ age ≤70 years old, regardless of gender; 3. 18 kg/m2≤bmi≤30 kg/m2; 4. american society of anesthesiologists (asa) grade ⅰ-ⅲ; 5. within 4 hours after the end of surgery, nrs≥4 in the resting state at any time; 6. before starting trial-related activities, participants should voluntarily sign the informed consent form, fully understand the purpose and significance of this trial, and voluntarily abide by the trial procedures. exclusion criteria: 1. patients with a previous history of difficult airway (obstructive sleep apnea syndrome), severe respiratory depression such as oxygen saturation \< 90%, or a history of acute or severe bronchial asthma; 2. patients with a history of severe cardiovascular and cerebrovascular diseases (such as myocardial infarction or unstable angina pectoris, or severe arrhythmia such as atrioventricular block of degree ⅱ or above, or ischemic stroke in nyha class ⅱ or above); 3. known or suspected gastric bowel obstruction, including paralytic ileus patients; 4. patients with allergy to opioids or any component of the trial drug; 5. subjects with previous psychiatric disorders (such as schizophrenia, depression, etc.) and cognitive impairment; 6. with late-stage malignant tumors or with extensive metastasis of malignant tumor patients; 7. subjects with other somatic pain that may affect postoperative pain assessment; 8. a history of drug, drug, and/or alcohol abuse within 1 year before randomization; 9. pregnant or lactating female subjects; 10. subjects with any other factor considered by the investigator to be ineligible for participation in the trial.

Keywords: analgesia biased μ-opioid receptor agonists
comparison of outcomes of bi-flanged metal stent alone versus bi-flanged metal stent with co-axial plastic stent for drainage of walled-off pancreatic necrosis - a prospective randomised controlled study.

Conditions: ENDOSCOPIC ULTRASONOGRAPHY

Summary: endoscopic ultrasound guided drainage of won with metal stent is the mainstay of won management. but there are few complications related to bfms , like bleeding due to vessel erosion, stent clogging , stent migration . this study is to assess, whether placing an anchoring dps through the bfms will decrease adverse events or not. there are only 2 retrospective studies till date ,comparing lams with coaxial stent vs lams alone. one study showed no significant decrease in adverse events , one study showed decrease in adverse events when dps with lams . but there has been no prospective rct to assess the utility of dps to date

inclusion criteria: - 1. symptomatic walled-off pancreatic necrosis (won) 2. eligible for eus guided bfms placement 3. signed informed consent . 4. age \>18 years exclusion criteria: - 1. types of pancreatic collections other than won . 2. drainage with stents other than bfms 3. previous attempts at drainage of won 4. coagulopathy (inr\>1.5) or thrombocytopenia(plc \<50000/cmm)- not correctable. 5. pregnancy 6. not willing to give informed consent

Eligibility criteria:
inclusion criteria: 1. symptomatic walled-off pancreatic necrosis (won) 2. eligible for eus guided bfms placement 3. signed informed consent . 4. age \>18 years exclusion criteria: 1. types of pancreatic collections other than won . 2. drainage with stents other than bfms 3. previous attempts at drainage of won 4. coagulopathy (inr\>1.5) or thrombocytopenia(plc \<50000/cmm)- not correctable. 5. pregnancy 6. not willing to give informed consent
the effect of releasing the tourniquet in total knee replacement before closure on the blood loss , joint effusion , hematoma formation and wound complication

Conditions: Hematoma; Arthroplasty Complications

Summary: the study , observe the effect of releasing the tourniquet in total knee replacement surgery before closure in comparison with releasing it after wound closure the effect was assessed by hb drop post operative and hematoma formation ( measured by ultrasound ) as well as the wound complication

the study is conducted in tertiary university hospital as a referral hospital for joint arthroplasty , the patients was informed about the study and consent was taken , the same operator , same theater and the same prosthesis company as well as the same radiologist during the study period. the patient randomly assigned to either group a (tourniquet release before closure of the wound and hemostasis ensured ) , or a group b ( tourniquet release after wound closure ) post operative hb drop was studied between the groups , and each patient underwent ultrasound measurement of the intraarticular hematoma . the wound complication between the groups was also studied .

Eligibility criteria:
inclusion criteria: * primary knee osteoarthrosis exclusion criteria: * rheumatoid arthritis * post traumatic arthritis * revision knee replacement * patients on anticoagulant/antiplatelet except acetylsalicylic acid 80-100 mg

Keywords: tourniquet intra articular hematoma total knee replacement
dialectical cognitive traumatherapy (dct) on patients with severe ptsd following sexual abuse

Conditions: Posttraumatic Stress Disorder

Summary: the purpose of this study is to determine whether dialectical cognitive traumatherapy is effective in the treatment of severe and chronic posttraumatic stress disorder (ptsd) following childhood sexual abuse.

most studies on psychological treatments for ptsd exclude patients with severe, co-occurring psychopathology. we designed a new treatment (dialectical cognitive trauma therapy, or dct) specifically to treat these patients. dct includes elements of emotion regulation, mindfulness exercises, cognitive and exposure treatment, as well as new elements. this randomized controlled study evaluates the effect of inpatient dct on these patients.

Eligibility criteria:
inclusion criteria: * female * minimum age of 17 * childhood sexual abuse * posttraumatic stress disorder (criteria of scid) * at least one of the following diagnoses: anorexia nervosa, or bulimia nervosa, or substance abuse, or substance dependence, or major depression or at least 4 out of 9 criteria for borderline personality disorder exclusion criteria: * diagnosis of schizophrenia * mental retardation * body mass index lower than 16.5 * acute delirium * perilous selfharming behaviour during the last 4 month * suicide attempt with the distinct intention to die during the last 4 month * unstability (e.g. homelessness, acute victimisation by offender) * pretreatment by dct

Keywords: dialectical cognitive therapy clinical psychology
all on six versus parallel implant distribution for maxillary denture opposing mandibular all on four

Conditions: Peri-Implantitis; Occlusal Trauma; Implant Complication

Summary: thirty maxillary edentulous patients with previous mandibular all-on-4 screw retained prosthesis and their age ranged from 55 to 65 years were selected from the outpatient clinic, of prosthodontics department, faculty of dentistry, mansoura university from march 2022 to july2022 and 80% power was used to calculate patients sample according to the results of a previous study 1 which showed no significant difference was reported when comparing occlusal stability ,implant stability and periimplant soft tissue changes between different implants angulation of both groups. (effect size=.70mm and α=.05). the power analysis was performed using the g\*power program (version 3.1.5, kiel, germany)

the aim of this study is to compare between all-on-six distributed dental implants "anterior 4 implant parallel and posterior 2 implant distally tilted" versus parallel distribution supporting screw retained maxillary single denture regarding soft tissue changes around implants, implant stability and occlusal stability. the primary outcome is to study implant stability and occlusal stability. the secondary outcome is to evaluate periimplant soft tissue changes. the null hypothesis of this study will be there is no difference between the two studied groups.all patients were informed about the proposal of this study, the line of treatment, and the need for regular and frequent recalls. their acceptance to participate in this study was confirmed and they signed the consent form of the ethical committee of the faculty of dentistry. this study gained the approval of the ethical committee of the faculty of dentistry, with approval number (a05080622). all the patients were divided randomly into two equal groups as follows group i patients received four axially placed anterior implants(\*general system) in lateral and first premolar region and two distally tilted 30 degree posteriorly in molar region relative to the occlusal plane supporting screw retained maxillary single denture. group ii patients received 6 implants in parallel distribution in anterior, premolar and molar region

Eligibility criteria:
inclusion criteria: * patient with maxillary edentulous alveolar ridges. * patient complained from insufficient retention and stability of their maxillary single denture. exclusion criteria: * medically compromised patients. * patients with parafunctional habits.

Keywords: soft tissue changes occlusal stability implant stability
contrast-enhanced intraoperative ultrasound during liver surgery for colorectal cancer liver metastases

Conditions: Colon Cancer Liver Metastasis

Summary: contrast-enhanced intraoperative ultrasound (ce-ious) during surgery for colorectal liver metastases (clm) has become a part of clinical practice. however, if it should be selectively or routinely applied remains unclear. this study is carried out to clarify which are the criteria for a selective use of ce-ious if any.

contrast-enhanced intraoperative ultrasound (ce-ious) during surgery for colorectal liver metastases (clm) is entered in clinical practice. however, its impact seems to decrease with the improvement of preoperative imaging. therefore, if ce-ious should be selectively or routinely applied remains unclear: a profile of patients who may benefit of ce-ious application has to be disclosed. the aim of this study is to define reliable criteria for a selective use of ce-ious during surgery for clm. ious is performed using 3-6 mhz convex probe, and a 7.5-10 mhz micro convex probe. staging is completed by ce-ious using the standard 3-6 mhz convex probe and the dedicated 1.88-3.76 mhz harmonic frequency probe. in all patients, 2.4 ml of sulphur-hexafluoride microbubbles (sonovue®, bracco, milan, italy) are injected through a peripheral vein by the anesthesiologist. ultrasound guidance is used to drive the dissection plane as previously described. reference standards are histology and imaging at 6 months after surgery. univariate and multivariate analyses are performed. statistical significance is set at p=0.05.

Eligibility criteria:
inclusion criteria: * consecutively enrolled patients with clm who underwent surgery and during this procedure received ious and ce-ious. * each patient had at least 6 months of postoperative follow-up. exclusion criteria: * patients who after ious and ce-ious had explorative laparotomy only were excluded from the analysis since there was no histological confirmation of the tumor and most of them were lost to surgical follow-up

Keywords: clm
local pharmacokinetics and tolerability of bimatoprost applied to the scalp of male patients with androgenetic alopecia

Conditions: Androgenetic Alopecia

Summary: this study will evaluate the skin pharmacokinetics and tolerability of bimatoprost formulation a and formulation b following 14 days of once daily topical administration in male participants with androgenetic alopecia (aga).

single-center, multiple-dose study evaluting the local pharmacokinetics and tolerability of bimatoprost following 14 days of once daily topical administration of bimatoprost formulation a and formulation b (both containing 1% bimatoprost) to the scalp of male patients with androgenetic alopecia

Eligibility criteria:
inclusion criteria: -patients with mild to moderate androgenetic alopecia of the vertex area of the scalp. exclusion criteria: * patients with uncontrolled systemic disease * history of significant cardiovascular disease * scarring disease, infection, or abnormality of the scalp or hair shaft or systemic disease that could cause temporary hair loss (eg, seborrheic dermatitis, psoriatic dermatitis, alopecia areata, cicatricial alopecia, uncontrolled hyperthyroidism/hypothyroidism, tinea infections, and genetic disorders) * patients who have received hair transplants or have had scalp reductions * abnormal bone biomarker laboratory results.
phase i-ii study with tumor molecular pharmacodynamic (mpd) evaluation and pharmacokinetics of pd-0332991 in patients suffering metastatic melanoma

Conditions: Melanoma BRAF V600E/K Mutated; CDNKN2A Loss Defined

Summary: an open label multicentre, phase i-ii study with tumour molecular pharmacodynamics (mpd) evaluation and pharmacokinetics of pd-0332991 added to vemurafenib in patients suffering metastatic melanoma with br. the main objective is to establish the maximum tolerated dose (mtd) of pd-0332991 when added to standard vemurafenib therapy (960 mg bid). the estimated mtd is defined as the dose of pd-0332991 combined with vemurafenib that will be associated with a prespecified proportion of patients experiencing a dose-limiting toxicity (dlt), ie, 1/3.


Eligibility criteria:
inclusion criteria: * age \> 18 years * stage iv or un-resectable stage iii melanoma * presence of braf v600e/k mutation and cdnkn2a loss and expression of rb using immunohistochemistry in a recent metastatic sample (\< 6 months) * a previous exposure to braf inhibitor or combination of braf and mek inhibitors therapy is allowed unless it has been stopped more than 3 months before study enrolment(this will defined the two strata of the trial) * no previous therapy by mek inhibitor unless associated with braf inhibitors * no previous therapy with the akt/pi3k pathway inhibitor * patients should have a tumour available for repeated biopsies for pharmacodynamics evaluation * life expectancy of \> 3 months * ecog performance status \<2 * signed informed consent * patient with health insurance coverage * no patient under guardianship or curators exclusion criteria: * inadequate hepatic function defined as serum bilirubin\>25 μmol/l, transaminases \> 3.0 times the upper limit of normal (uln) or 5uln in cases of liver metastases; * inadequate bone marrow function defined as absolute neutrophil count\<1500/mcl, platelets\<150000/mcl and haemoglobin\<8g/dl * inadequate renal function with serum creatinine\>2.0mg/dl) and /or creatinine clearance\< 60 ml/min * untreated brain metastases : patients with brain metastases will be eligible if they have completed treatment 1 months prior to the start of study medication, have discontinued corticosteroid treatment for these metastases for at least 5 days, and are neurologically asymptomatic * myocardial infarct or unstable angina within the past 6 months * concomitant take of drugs known to be strong inhibitor or inducers of cyp314 * hiv positive. * chemotherapy, immunotherapy within 4 weeks * drugs interfering with pd-0332991 and vemurafenib metabolism * malabsorption syndrome or other condition that would interfere with enteral absorption * congenital long qt syndrome or screening qtc \> 470 msec * need for chronic corticosteroid therapy of ≥10 mg of prednisone per day

Keywords: melanoma braf mutated
study of anti-atherosclerotic activity of karinat in postmenopausal women

Conditions: Atherosclerosis

Summary: the purpose of this study is to investigate the anti-atherosclerotic action of natural drug karinat based on phytoestrogen-rich botanicals in postmenopausal women.


Eligibility criteria:
inclusion criteria: * women at least 5 years after menopause * maximum intima-media thickness of common carotid artery more than 0,80 mm (ultrasonographic b-mode examination) * the absence of climacteric syndrome (less than 3 points by blatt-kupperman scale) * the absence of chronic diseases demanding permanent drug administration (more than 2 month per year) * the absence of hypolipidemic therapy or hormone replacement therapy during 6 months before the inclusion exclusion criteria: * administration of lipid-lowering drugs, and/or hormone replacement therapy, and/or phytoestrogens during 6 month before inclusion * continuous administration of sulfonylurea derivatives, and/or beta-blockers, and/or calcium antagonists (more than 2 months per year) * personal history or diagnostic of following diseases: 1. personal history of stroke, coronary heart disease, acute myocardial infarction or transient ischemic attacks 2. pulmonary thromboembolism 3. chronic heart failure iia-iii 4. uncontrolled arterial hypertension (systolic blood pressure \> 145 mmhg, diastolic blood pressure \> 95 mmhg under hypotensive therapy) 5. malignancy 6. chronic renal failure ii-iii 7. chronic hepatic failure ii-iii 8. liver cirrhosis 9. individual intolerance of karinat or major side effects

Keywords: postmenopause phytoestrogen atherosclerosis intima-media thickness
cardiovascular effects of a healthy dietary pattern containing eggs

Conditions: Cardiovascular Diseases

Summary: this study will examine the effect of a healthy diet containing 2 eggs per day compared to a healthy diet containing 3 eggs per week on biomarkers of heart health after 4 weeks.

this is a 2-period, randomized, crossover, controlled feeding study examining the effect of 2020-2025 dietary guidelines for americans adherent dietary patterns containing 2 eggs/day/2000 kcal (hd+e) compared to 3 eggs/week/2000 kcal (hd) on biomarkers of cardiovascular health and function after 4 weeks.

Eligibility criteria:
inclusion criteria: * ldl-c ≥115 mg/dl and ≤190 mg/l * bmi of 25-35 kg/m2 * intake of \<14 eggs/week for the prior 3 months * blood pressure \<140/90 mmhg * fasting blood glucose \<126 mg/dl * fasting triglycerides \<350 mg/dl * ≤10% change in body weight in the prior 6 months exclusion criteria: * type 1 or type 2 diabetes or fasting blood glucose ≥126 mg/dl * prescription of anti-hypertensive, lipid lowering or glucose lowering drugs * intake of supplements that affect the outcomes of interest and unwilling to cease during the study period * diagnosed liver, kidney, or autoimmune disease * prior cardiovascular event (e.g., stroke, heart attack) * current pregnancy or intention of pregnancy within the next 6 months * lactation within prior 6 months * follows a vegetarian or vegan diet * food allergies/intolerance/sensitives/dislikes of foods included in the study menu * antibiotic use within the prior 1 month * oral steroid use within the prior 1 month * use of tobacco or nicotine containing products with in the past 6 months * cancer any site within the past 10 years (eligible if ≥10 years without recurrence) or non-melanoma skin cancer with in the past 5 years (eligible if ≥5 years without recurrence) * participation in another clinical trial within 30 days of baseline * currently following a restricted or weight loss diet * prior bariatric surgery * intake of \>14 alcoholic drinks/week and/or lack of willingness to consume a maximum of two standard drinks per week while enrolled in the study and/or not willing to avoid alcohol consumption for 48 hour prior to test visits
gateway: a phase 2a study of port-77 in adults with erythropoietic protoporphyria

Conditions: Erythropoietic Protoporphyria (EPP)

Summary: a phase 2a study of port-77 in adults with erythropoietic protoporphyria (epp)


Eligibility criteria:
major inclusion criteria: * bmi ≥18.0 and ≤35.0 kg/m2 and weight ≥50 kg * known diagnosis of epp and is currently symptomatic even if receiving treatment for epp, including afamelanotide. * willing and able to avoid exposure to sunlight when outside of the clinical research site. * willing and able to follow protocol-specified contraception guidance. * able to read and understand english * able to understand the study procedures as described in the icf and is willing and able to comply with the study requirements. major exclusion criteria: * is mentally or legally incapacitated * history or presence of any illness or clinically significant medical or psychiatric condition or disease that, in the opinion of the pi or designee, might confound the results of the study or pose an additional risk to the participant by their participation in the study. * history of gastrointestinal condition, including surgeries, which may affect absorption after oral administration. * history of cancer, with the exception of cutaneous non-melanoma skin cancer (basal or squamous cell carcinoma). * participation in another clinical study within 28 days or within 5 half-lives (if known), prior to screening * unable to refrain from or anticipates the use of medications/supplements known to confound port-77 beginning 28 days (or 5 half-lives, whichever is longer) prior to the first dose of study drug and throughout the study. * estimated glomerular filtration rate \<80 ml/min/1.73 m2 using the ckd-epi equation at screening * hepatic impairment, with alanine aminotransferase, aspartate aminotransferase, or total bilirubin \>1.5 x uln at screening * female participant with a positive pregnancy test at screening or who is breastfeeding.

Keywords: port-77 epp erythropoietic protoporphyria